Janssen’s Teclistamab Receives the US FDA’s Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma

June 2, 2021 Auto Bot Breakthrough Therapy Designation, FDA, Janssen, multiple myeloma, Refractory, regulatory, Relapsed, Teclistamab 0

Shots:

  • The FDA’s BT and EMA’s PRIME designations are based on data from the P-I MajesTEC-1 study evaluating the safety and efficacy of teclistamab (Ab targeting BCMA and CD3) in adults with r/rMM. The findings will be presented at ASCO 2021
  • In preclinical studies, the therapy kills myeloma cell lines and bone marrow-derived myeloma cells from heavily pretreated patients
  • The company is also evaluating the therapy in a P-II clinical study for r/MM and also in combination studies. The EMA has granted PRIME designations for Teclistamab in Jan’2021

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Ars Technica

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